The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Monitoring, safety and shortages
Your responsibilities do not stop once your therapeutic good is on the market. Please find information below about further monitoring of your product, reporting adverse events and shortages.
Latest alerts
-
We are aware of products being sold in Australia that claim to contain, or influence the levels of, nicotinamide adenine dinucleotide (NAD, NAD+, NADH) or nicotinamide mononucleotide (NMN) in the body.
-
Gold Max Blue capsules pose a serious risk to your health and should not be taken.
-
We have become aware of an increasing number of cases of liver injury reported in scientific literature, by consumers who had taken products containing Garcinia gummi-gutta.
Latest articles
-
Product Information safety updates - March 2025
Information for health professionals about medicines with safety related updates to their Product Information. -
Nitrosamine and Nitroso-structure impurities acceptable intakes update
We are updating information for nitrosamine impurities and other nitroso-structure impurities in medicines including acceptable intakes (AI) -
Recall reforms update and new procedure
Recall reforms program update and preview of the PRAC Version 1.0.
Latest publications
-
Advisory Committee on Vaccines meeting Statement 49 for meeting held 2 October 2024
-
This web publication constitutes a notice for the purposes of regulations 42ZCZS of the Therapeutic Goods Regulations 1990 (the Regulations).
-
This web publication constitutes a notice for the purposes of regulations 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations).
Resources
-
Templates to help you with your communications under the Procedure for Recalls, Product Alerts and Product Corrections (PRAC).
-
We have adopted this International Scientific Guideline - EMA/HMPC/104613/2005 Rev.1.
-
We have adopted this International Scientific Guideline – ICH Q5A(R1); CPMP/ICH/295/95
Latest consultations
-
This consultation paper seeks feedback on proposals identified for mitigating risks and leveraging opportunities associated with the use of AI models.
-
The TGA sought feedback from interested parties on proposed changes to the requirements of ingredients used in listed (low-risk) medicines.
-
Have your say about proposed changes to address 3 medicine safety matters needing action, before we review labelling rules more broadly.